Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 223-423-4 | CAS number: 3886-69-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Oral: The median lethal oral dose was found to be greater than 300 mg/kg bw and less or equal than 2000 mg/kg bw in rats.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2011-12-05 to 2012-01-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP and guideline compliant study. Study was performed with the Racemat (DL-alpha-methylbenzylamine). Read across is done to D-alpha-methylbenzylamine, as the substance is expected to behave similar to the racemat with regard to acute toxicity properties. For read-across justification please refer to IUCLID section 13.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- (17 December 2001)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- (30 May 2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- (December 2002)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nosan No. 8147
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: 10 weeks
- Weight at study initiation: Mean weight 180.3-209.3 g
- Fasting period before study: 16 hours before administration
- Housing: Single housing, Makrolon cage, type III
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water: Tap water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30–70
- Air changes (per hr): Central fully air-conditioned
- Photoperiod (hrs dark / hrs light): 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.) - Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 15 g /100 mL (300 mg/kg bw )
- Justification for choice of vehicle: Solution in olive oil Ph.Eur.
MAXIMUM DOSE VOLUME APPLIED
An administration volume of 2 mL/kg bw of suitable test item preparation was used to facilitate application. - Doses:
- 2000 mg/kg bw (undiluted)
300 mg/kg bw ( 15 g/100 mL) (2 administrations) - No. of animals per sex per dose:
- 3 animals/dose
2 replicates - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observation: At least once daily; Weighing: Day 0, 7, 14
- Necropsy of survivors performed: Yes
- Other examinations performed: Pathology, mortality - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals of the 2000 mg/kg bw test group died immediately after administration. No mortality occurred in both 300 mg/kg bw test groups.
- Clinical signs:
- other: Because all animals of the 2000 mg/kg bw test group died immediately after administration no clinical signs could be determined. In the first and second test group 300 mg/kg bw following obseravtions were made: · Impaired general state in 5 out of 6
- Gross pathology:
- The macroscopic pathological findings in the animals of the 2000 mg/kg bw test group revealed red discoloration in all lobes of the lung, dark discoloration of the liver and extensive bleeding in the glandular stomach.
Additionally one of these animals showed edema in all lobes of the lung. There were no macroscopic pathological findings in the animals of both 300 mg/kg bw test groups sacrificed at the end of the observation period.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 300 mg/kg bw
- Quality of whole database:
- Only one GLP and guideline compliant study available.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Read-across
No data were available for D-alpha-methylbenzylamine. Study was performed with the Racemat (DL-alpha-methylbenzylamine). Read across is done to D-alpha-methylbenzylamine, as the substance is expected to behave similar to the racemat with regard to acute toxicity properties. For read-across justification please refer to IUCLID section 13.
Oral
In an acute oral toxicity study performed with the racemat according to the Acute Toxic Class method, doses of 2000 and 300 mg/kg bw of the test item 1-Phenylethylamine (undiluted or preparations in olive oil Ph.Eur) were administered to three test groups of three fasted Wistar rats each (2000 mg/kg bw in 3 females, 300 mg/kg bw in 6 females) by gavage in a sequential manner. The following test substance-related clinical observations were recorded: 2000 mg/kg (first test group): All animals died immediately after application. Therefore no clinical signs were observed. Macroscopic pathological findings were made in the animals that died: Red discoloration and edema in all lobes of lung; Dark discoloration of the liver; Extensive bleeding in the glandular stomach
At the concentration of 300 mg/kg (both test groups) no mortality occurred . The following clinical oberservation were made: Impaired general state in 5 out of 6 animals; Poor general state in 2 out of 6 animals; Dyspnoea in 5 out of 6 animals; Piloerection in 5 out of 6 animals; Staggering in 1 out of 6 animals; Abdominal position in 1 out of 6 animals; Exsiccosis in 1 out of 6 animals; Reduced feces in all animals. The mean body weight increased within the normal range throughout the study period. There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period. The acute oral LD50 was calculated to be > 300 <= 2000 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
GLP and guideline compliant study.
Justification for classification or non-classification
No data were available for D-alpha-methylbenzylamine. Studies were performed with the racemat (DL-alpha-methylbenzylamine, read across, CAS 618-36-0). Based on the available data for DL-alpha-methylbenzylamine, D-alpha-methylbenzylamine is subject to C&L:
according to Regulation 1272/2008/EC: acute oral tox. 4, H302; acute dermal tox. 4, H312
according to Directive 67/548/EEC: acute oral tox.: R22; acute dermal tox.: R21
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.